A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth.

Radiation: Proton Beam Radiotherapy

Fifteen consecutive sessions

Drug: Sorafenib

400 mg po bid

Active Comparator: Sorafenib

Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level.

Drug: Sorafenib

400 mg po bid

Eligibility

Ages Eligible for Study:

18 Years to 80 Years (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients are candidates to receive both proton beam and sorafenib

Patients with tumor burden that exceeds San Francisco criteria

Exclusion Criteria:

Patients who are candidates for surgical resection

Patients with tumor burden within Milan and/or San Francisco criteria

Patients who have contraindication to receive proton

Patients with contraindication to receive sorafenib including uncontrolled hypertension, coumadin treatment and prior intolerability to the drug

Patients treated previously by any locoregional treatment

Patients with prior liver transplant

Patients with child class C

Patients with model for end-stage liver disease (MELD) score of > 25

Patients with other comorbid diseases that may impact survival

Patients with ongoing alcohol intake

Patients with active sepsis

Patients with gastrointestinal bleeding within a week

Patients unwilling to sign informed consent form

Patients with history of noncompliance

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141478